Multiple SclerosisNCT02225977
Assessing Induction of Type II (M2) Monocytes/Macrophages in Patients Receiving Gilenya.
An observational study of Multiple Sclerosis, run by University of Southern California at 1 site in United States.
Trial summary
In this study we wish to test the hypothesis that continuous Gilenya treatment alters immune homeostasis in favor of an anti-inflammatory type II monocyte and macrophage (M2) phenotype in the circulation of patients with relapsing-remitting Multiple Sclerosis (MS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Gilenya
- Type of treatment
- Pill or oral medicine
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2013to 30 Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be selected from those seen by physicians at the USC Multiple Sclerosis Comprehensive Care Center.
Who may be able to join
- Patients must qualify to receive treatment with Gilenya, according to the University of Southern California, Department of Neurology, MS Group, Gilenya Prescribing Process.
- Clinically definite Multiple Sclerosis defined by the revised McDonald criteria (Polman et al., 2005, Polman et al., 2010) of the relapsing-remitting form with an Expanded Disability Status Scale (EDSS) score of 0 to 5.5.
- Ability to understand and sign this study-specific institutional review board-approved informed consent form.
- Willing to donate ~50mls of blood for immunological testing on up to five occasions.
Who cannot join
- Patient does not qualify to receive treatment with Gilenya, according to the USC, Department of Neurology, MS Group, Gilenya Prescribing Process.
- Inability to understand nature of the study.
- Treatment with any of the following within 30 days of commencing treatment with Gilenya: Avonex, Betaseron, Rebif, Copaxone, Natalizumab, Rituximab, Mitoxantrone, Cyclophosphamide, Cyclosporine, Azathioprine, Methotrexate or any other immunomodulatory, immunosuppressant or immune homeostasis altering drug.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California, Department of Neurology
Los Angeles, California, 90033
About this study
In this study we wish to test the hypothesis that continuous Gilenya treatment alters immune homeostasis in favor of an anti-inflammatory type II monocyte and macrophage (M2) phenotype in the circulation of patients with relapsing-remitting Multiple Sclerosis (MS). In this study we will determine the change in ratio of M2 (type II, alternatively activated) versus M1 (type I, classically activated) monocytes and macrophages in a cohort of patients that have received continuous Gilenya treatment for 0, 1, 3, 6 or 12 months. We will also assess changes in cell surface expression of the M1 marker CCR7 and the M2 markers CD206 or CD301 by monocytes and macrophages using FACS analysis of whole blood, and assess the tyrosine phosphorylation of the signal transducer and activator of transcription STAT-1 (pTyr-STAT1), which is critical for the activation of M1 myeloid cells. We will assess correlates with changes in M1 and M2 cytokine expression assessing possible mechanisms of action of Gilenya on myeloid lineage cells.
- Conditions
- Multiple Sclerosis
- Being tested
- Gilenya
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GilenyaDrug
| Study group | Role | What they receive |
|---|---|---|
| Gilenya treated - 1 month | Patient's taking continuous oral Gilenya at prescribed dose for 1 month. Receives: Drug: Gilenya | |
| Gilenya treated - 3 months | Patient's taking continuous oral Gilenya at prescribed dose for 3 months. Receives: Drug: Gilenya | |
| Gilenya treated - 6 months | Patient's taking continuous oral Gilenya at prescribed dose for 6 months. Receives: Drug: Gilenya | |
| Gilenya treated - 12 months | Patient's taking continuous oral Gilenya at prescribed dose for 12 months. Receives: Drug: Gilenya | |
| Gilenya qualified - untreated | Patient's qualifying to start treatment with oral Gilenya at prescribed dose but still as yet untreated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ratio of M2 versus M1 monocytes and macrophages.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study start31 Jul 2013
- Primary completion31 Dec 2016
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brett T. Lund, University of Southern California
- Investigators
- Brett T Lund, Ph.D., Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225977
- Sponsor's protocol ID
- MSGilenya
- Status last verified
- Aug 2018
- First submitted
- 24 Aug 2014
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Induction of Type II (M2) Monocytes/Macrophages in Patients Receiving Gilenya.
- ClinicalTrials.gov ID
- NCT02225977
- Acronym / sponsor ID
- MSGilenya
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 31 Jul 2013 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 26 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study we wish to test the hypothesis that continuous Gilenya treatment alters immune homeostasis in favor of an anti-inflammatory type II monocyte and macrophage (M2) phenotype in the circulation of patients with relapsing-remitting Multiple Sclerosis (MS). In this study we will determine the change in ratio of M2 (type II, alternatively activated) versus M1 (type I, classically activated) monocytes and macrophages in a cohort of patients that have received continuous Gilenya treatment for 0, 1, 3, 6 or 12 months. We will also assess changes in cell surface expression of the M1 marker CCR7 and the M2 markers CD206 or CD301 by monocytes and macrophages using FACS analysis of whole blood, and assess the tyrosine phosphorylation of the signal transducer and activator of transcription STAT-1 (pTyr-STAT1), which is critical for the activation of M1 myeloid cells. We will assess correlates with changes in M1 and M2 cytokine expression assessing possible mechanisms of action of Gilenya on myeloid lineage cells.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Gilenya treated - 1 month | – | Drug: GilenyaPatient's taking continuous oral Gilenya at prescribed dose for 1 month. |
| Gilenya treated - 3 months | – | Drug: GilenyaPatient's taking continuous oral Gilenya at prescribed dose for 3 months. |
| Gilenya treated - 6 months | – | Drug: GilenyaPatient's taking continuous oral Gilenya at prescribed dose for 6 months. |
| Gilenya treated - 12 months | – | Drug: GilenyaPatient's taking continuous oral Gilenya at prescribed dose for 12 months. |
| Gilenya qualified - untreated | – | –Patient's qualifying to start treatment with oral Gilenya at prescribed dose but still as yet untreated. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be selected from those seen by physicians at the USC Multiple Sclerosis Comprehensive Care Center.
Key inclusion criteria (4 listed)
- Patients must qualify to receive treatment with Gilenya, according to the University of Southern California, Department of Neurology, MS Group, Gilenya Prescribing Process.
- Clinically definite Multiple Sclerosis defined by the revised McDonald criteria (Polman et al., 2005, Polman et al., 2010) of the relapsing-remitting form with an Expanded Disability Status Scale (EDSS) score of 0 to 5.5.
- Ability to understand and sign this study-specific institutional review board-approved informed consent form.
- Willing to donate ~50mls of blood for immunological testing on up to five occasions.
Key exclusion criteria (3 listed)
- Patient does not qualify to receive treatment with Gilenya, according to the USC, Department of Neurology, MS Group, Gilenya Prescribing Process.
- Inability to understand nature of the study.
- Treatment with any of the following within 30 days of commencing treatment with Gilenya: Avonex, Betaseron, Rebif, Copaxone, Natalizumab, Rituximab, Mitoxantrone, Cyclophosphamide, Cyclosporine, Azathioprine, Methotrexate or any other immunomodulatory, immunosuppressant or immune homeostasis altering drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gilenya | Drug | Gilenya treated - 1 month, Gilenya treated - 12 months, Gilenya treated - 3 months, Gilenya treated - 6 months |
Primary outcome
Change in ratio of M2 versus M1 monocytes and macrophages.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brett T Lund, Ph.D. principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ratio of M2 versus M1 monocytes and macrophages. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.